Orfadin Capsule
Product Images NDC 66658-102

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Orfadin (NDC 66658-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Swedish Orphan Biovitrum Ab (publ), these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Orf01 0015 01

Chemical structure of the active ingredient Nitisinone. The diagram shows a benzene ring substituted with trifluoromethyl and nitro groups, connected to a cyclic ketone structure.*

FDA Label Image

Orf01 0015 02

An instructional illustration showing three objects: an oral syringe labeled with parts 'Black line,' 'Barrel,' and 'Plunger'; a bottle with a blank label; and an adapter labeled 'Ribbed end.' The diagram appears to demonstrate components related to medication administration.*

FDA Label Image

Orf01 0015 03

An instructional illustration showing a hand gripping a bottle and shaking it in an up-and-down motion. The image likely indicates how to properly mix or prepare the contents before use.*

FDA Label Image

Orf01 0015 04

An instructional illustration showing a person using both hands to open a bottle by twisting the cap counterclockwise, indicating how to open the container safely.*

FDA Label Image

Orf01 0015 05

An illustration showing two hands opening a bottle with a child-resistant cap, indicated by a downward arrow pointing to the cap. The image demonstrates the technique to open the bottle safely, likely for oral capsules of Orfadin (Nitisinone). The bottle label is blank in the image.*

FDA Label Image

Orf01 0015 06

An instructional illustration showing a hand holding a bottle with a flip-top cap, demonstrating how to open the cap by flipping it upward and downward.*

FDA Label Image

Orf01 0015 07

An instructional illustration showing two hands opening a child-resistant bottle cap. One hand holds the bottle while the other presses down and turns the cap counterclockwise to open the bottle.*

FDA Label Image

Orf01 0015 08

An instructional illustration showing two hands holding a capsule vial with one hand lifting the cap upwards, demonstrating how to open the vial by pulling the cap off vertically.*

FDA Label Image

Orf01 0015 09

Illustration showing a hand holding a bottle while another hand inserts a syringe into the bottle's opening. An arrow indicates the downward motion of the syringe plunger. The image depicts a procedure for withdrawing liquid from a bottle, but does not show specific product details.*

FDA Label Image

Orf01 0015 10

An instructional line drawing showing a hand holding a medication bottle with a dropper tip being pulled from the opening. A magnified inset highlights the textured or granular surface inside the bottle opening.*

FDA Label Image

Orf01 0015 11

An instructional illustration showing a hand holding an oral liquid medication bottle upside down and dispensing liquid into an oral syringe. A zoomed-in inset highlights the measurement markings on the syringe (0.5 ml to 1.5 ml) indicating the volume to be drawn for accurate dosing.*

FDA Label Image

Orf01 0015 12

An instructional black-and-white illustration showing a person holding a bottle with one hand and using the other hand to twist and remove a dropper cap from the bottle. The image demonstrates how to open the bottle by twisting the dropper cap.*

FDA Label Image

Orf01 0015 13

An instructional illustration showing a person administering medication orally using a syringe-like device aimed at the mouth. The image depicts hand positioning and the proper method to deliver oral medication.*

FDA Label Image

Orf01 0015 14

An instructional illustration showing a person opening a bottle by twisting the cap counterclockwise. The image focuses on hand positioning for removing the bottle cap safely.*

FDA Label Image

Orf01 0015 15

Orfadin Capsules 2 mg packaging label for oral use, containing 60 capsules. The active ingredient is Nitisinone. The label includes storage instructions to keep refrigerated at 2°C to 8°C and notes that the product may be kept at room temperature up to 25°C for 45 days. Manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc.*

FDA Label Image

Orf01 0015 16

Label for Orfadin Capsules containing 2 mg Nitisinone. The package contains 60 capsules for oral use. The label specifies refrigeration storage (2-8°C) and is manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc., Waltham, MA. The NDC number is 66658-102-60.*

FDA Label Image

Orf01 0015 17

Orfadin Capsules 5 mg packaging label showing the product name, active ingredient Nitisinone, strength 5 mg, and oral dosage form. The label states 60 capsules per package, includes storage instructions to refrigerate at 2–8°C or keep at room temperature up to 25°C for 45 days after opening. The labeler is Swedish Orphan Biovitrum AB (Sobi), with manufacturing by Apotek Produktion & Laboratorier AB, Sweden, and marketing by Sobi, Inc., Waltham, MA.*

FDA Label Image

Orf01 0015 18

Label for Orfadin Capsules 5 mg (Nitisinone) displays oral use, prescription-only status, and storage instructions. Manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc. The package contains 60 capsules. NDC 66658-105-60 is shown along with a mention of refrigeration and expiration date details.*

FDA Label Image

Orf01 0015 19

Packaging label for Orfadin Capsules (Nitisinone) 10 mg, containing 60 capsules for oral use. The label includes storage instructions to keep refrigerated at 2 to 8 °C (36 to 46 °F) or at room temperature up to 25 °C (77 °F) for up to 45 days. Manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc.*

FDA Label Image

Orf01 0015 20

Orfadin Capsules 10 mg label showing the active ingredient Nitisinone. The label includes storage instructions to keep refrigerated at 2-8 °C, Rx only, and directs to see the package insert. It indicates a package size of 60 capsules. Manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc. in Waltham, MA.*

FDA Label Image

Orf01 0015 21

The packaging label for Orfadin Capsules contains 20 mg Nitisinone for oral use. The label features the product name and strength prominently in purple text, with the NDC code 66658-120-60 and a count of 60 capsules. It also includes storage instructions, manufacturer details (Apotek Produktion & Laboratorier AB, Sweden), and marketer information (Sobi, Inc.). The label advises refrigeration between 2°C to 8°C, allows room temperature storage up to 25°C for 45 days, and directs users to see the package insert.*

FDA Label Image

Orf01 0015 22

Orfadin Capsules 20 mg label showing Nitisinone as the active ingredient. The label states the product contains 60 capsules, for oral use, prescription only, and should be stored refrigerated at 2-8 °C (36-46 °F). Manufactured by Apotek Produktion & Laboratorier AB, Sweden, and marketed by Sobi, Inc. The label includes the NDC number 66658-120-60 and spaces for expiration date and lot number.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.